Tobramycin Inhalation (Page 7 of 7)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — carton label

Tobramycin Inhalation Solution carton
(click image for full-size original)

NDC 66993-195-94

Prasco

Rx only

Tobramycin Inhalation Solution

300 mg/ 4 mL

For Oral Inhalation Only by Nebulizer

Single Use Only, Discard Each Ampule After One Use

Contents: Each single-use ampule delivers 4 mL
of solution containing 300 mg of Tobramycin
and 18 mg of sodium chloride in Water for Injection.

Usual Dose: See package insert for details.

Storage: Store in a Refrigerator at 2°C to 8°C (36°F to 46°F).

Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch.

Each carton contains 56 Single-Use Ampules (28-Day Supply)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — pouch label

Tobramycin Inhalation Solution foil pouch
(click image for full-size original)

NDC 66993-195-44

Prasco

Tobramycin Inhalation Solution

300 mg/ 4 mL

For Oral Inhalation Only by Nebulizer

Single Use Only. Discard Each Ampule After One Use.

Each foil pouch contains 4 ampules.

Storage: Store in a Refrigerator at 2°C to 8°C (36°F to 46°F). Protect from Intense Light.

Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch.

Contents: Each single-use ampule delivers 4 mL
of solution containing 300 mg of Tobramycinand 18 mg of sodium chloride in Water for Injection.

Usual Dose: See package insert for details.

Contains No Preservatives

Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — ampule label

Tobramycin Inhalation Solution ampule
(click image for full-size original)
TOBRAMYCIN INHALATION tobramycin inhalation solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-195
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 300 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SULFURIC ACID
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-195-94 14 POUCH in 1 CARTON contains a POUCH
1 4 AMPULE in 1 POUCH This package is contained within the CARTON (66993-195-94) and contains a AMPULE
1 4 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (66993-195-94)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA201820 09/15/2020
Labeler — Prasco, LLC (065969375)
Registrant — Chiesi USA, Inc. (088084228)

Revised: 05/2021 Prasco, LLC

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